Perio Pik
FDA 510(k) K840721 · Teledyne, Inc.
510(k) numberK840721
Submission
- Device name
- Perio Pik
- Applicant
- Teledyne, Inc.
Walker, MI, US - Received
- February 17, 1984
- Decision date
- April 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EFS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023232 | Splatrfree Swangle 360 Disposable Prophylaxis AngleEFS · Traditional | Smartpractice | 12/11/2002SE |
| K001493 | Dental Air Force Home Dental Cleaning System, Model No. 0020001EFS · Traditional | Air Force, Inc. | 10/25/2000SE |
| K983374 | AGATHA-A-H2010EFS · Traditional | Midian Intl. | 12/23/1998SE |
| K964810 | DermadamEFS · Traditional | Ultradent Products, Inc. | 02/10/1997SE |
| K952234 | Barrier All FilmEFS · Traditional | Cottrell, Ltd. | 07/31/1995SE |
| K943182 | Oral-B Perioflex Subgingival IrrigatorEFS · Traditional | Oral-B Laboratories | 09/09/1994SE |
| K923711 | Perioflex TipEFS · Traditional | Novadent, Ltd. | 05/16/1994SE |
| K923937 | Hydro FlossEFS · Traditional | Hydro Floss, Inc. | 02/25/1994SE |
| K931380 | Water Pik Plus Plaque Control SystemEFS · Traditional | Teledyne Water Pik | 09/20/1993SE |
| K923457 | ShowerflossEFS · Traditional | Summit Marketing Group, Inc. | 09/01/1992SE |
More from Summit Marketing Group, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871828 | Ted Model 760CCK · Traditional | 02/04/1988SE |
| K863131 | Pik Pocket (Irrigating Tip)EFS · Traditional | 08/26/1986SE |
| K862695 | Fluor-Etch Gel EtchantEBC · Traditional | 07/31/1986SE |
| K854817 | InstapureFRF · Traditional | 02/28/1986SE |
| K810864 | Water Pik Oral Hygiene CenterEFS · Traditional | 04/21/1981SE |
| K810805 | Water Pik Automatic ToothbrushJEQ · Traditional | 04/14/1981SE |
| K801593 | Lebody by Water PikISA · Traditional | 08/20/1980SE |
| K800919 | Oraview by Water PikEAX · Traditional | 05/08/1980SE |
| K800448 | Water Pik Traveler, Model 79EFS · Traditional | 03/05/1980SE |
Questions and answers
When was Perio Pik cleared by the FDA?
Perio Pik (K840721) received a 510(k) decision of Substantially Equivalent on April 25, 1984, 68 days after the submission was received.
What is the product code of K840721?
The FDA product code is EFS – Unit, Oral Irrigation, a Class I (low risk) device regulated under 21 CFR 872.6510.